MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	1260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that catheter detachment occurred.A mach1 6f was selected for use.However, as the physician introduced the catheter, it detached.The procedure was completed with the use of an alternative device.No patient complications were reported, and patient was good post procedure.
Event or Problem Description
It was reported that catheter detachment occurred.A mach1 6f was selected for use.However, as the physician introduced the catheter, it detached.The procedure was completed with the use of an alternative device.No patient complications were reported, and patient was good post procedure.
Additional Manufacturer Narrative
(b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic inspection of the device revealed that the shaft of the device was twisted at the strain relief of the hub.There were two holes with exposed braiding at the twisted shaft.The shaft was kinked 56.75 distal of the strain relief of the hub.The appearance of the damage is consistent to damage that can be caused during the procedure.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21697833
• Report Number: 2124215-2025-18614
• Device Sequence Number: 8667885
• Product Code: DQY
• UDI-Device Identifier: 08714729352082
• UDI-Public: (01)08714729352082(17)271120(10)60607188
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060607188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown